A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer

NCT04468607 | Completed Phase 1 FDA Drug

• 2 other identifiers: GO417512023-503409-12-00
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 6

Brief Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of BLYG8824A and will make a preliminary assessment of the anti-tumor activity of BLYG8824A in patients with locally advanced or metastatic colorectal cancer.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (5)

• Incidence and Nature of DLTs

  Approximately 48 months

• Number of Patricipants with Adverse Events

  Approximately 48 months

• Number Of Cycles Received

  Approximately 48 months

• Dose Intensity

  Approximately 48 months

• Maximum Tolerated Dose(s) MTD(s) of BLYG8824A

  Approximately 48 months

Secondary Outcomes (4)

• Serum Concentration of BLYG8824A

  At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)

• Overall Response Rate (ORR)

  Approximately 48 months

• Duration of Response (DOR)

  Approximately 48 months

• Presence of Anti-drug Antibodies (ADAs)

  Cycle 1, Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)

Study Arms (2)

Dose-Escalation Stage

EXPERIMENTAL

Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).

Drug: BLYG8824A

Dose-Expansion Stage

EXPERIMENTAL

Once dose escalation is completed and the MTD (or MAD) has been identified, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.

Drug: BLYG8824A

Interventions

BLYG8824A DRUG

BLYG8824A will be administered at a flat dose independent of body weight.

Also known as: linclatamig, RG6286

Dose-Escalation Stage; Dose-Expansion Stage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status of 0 or 1
• Life expectancy of at least 12 weeks
• Histologically or cytologically documented invasive CRC: incurable, unresectable, locally advanced or metastatic CRC previously treated with multimodality therapy or mCRC
• Locally advanced or metastatic CRC that has relapsed or is refractory to established therapies
• Prior disease progression (or intolerance) following oxaliplatin, irinotecan, fluoropyrimidines, and anti-EGFR monoclonal antibodies
• An archival tissue specimen or fresh baseline biopsy (when archival is not available) is required for enrollment into the study
• Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Non-measurable evaluable disease is acceptable for dose-escalation.
• Adequate hematologic and end organ function
• Acute, clinically significant treatment-related toxicity from prior therapy resolved to Grade ≤ 1 prior to study entry
• MSS or MSI-L disease as determined by polymerase chain reaction (PCR) and/or IHC
• Measurable disease by RECIST v1.1 with at least one measurable target lesion in the expansion cohort
• Progression must have occurred during or after most recent treatment for locally advanced or metastatic colorectal cancer
• For patients enrolled in either a dedicated biopsy cohort or other expansion cohorts where biopsy is clinically feasible, willingness to consent to mandatory fresh pretreatment and on-treatment biopsies of safely accessible tumor lesions

You may not qualify if:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of BLYG8824A
• Significant cardiopulmonary dysfunction
• Known clinically significant liver disease
• Positive serologic or PCR test results for acute or chronic HBV infection
• Acute or chronic HCV infection
• HIV seropositivity
• Poorly controlled Type 2 diabetes mellitus
• Current treatment with medications that are well known to prolong the QT interval
• Primary CNS malignancy, untreated CNS metastases, or active CNS metastases
• Leptomeningeal disease
• Spinal cord compression that has not been definitively treated with surgery and/or radiation
• History of autoimmune disease
• Prior allogeneic stem cell or solid organ transplantation

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (6)

City of Hope

Duarte, California, 91010, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

Location

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 13, 2020
• Study Start: August 31, 2020
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); ES (3); AU (1)